 |
Clinical Trial Questions?
|
|
|
Pilot Study of High-Dose Zidovudine and Valganciclovir, With or Without Bortezomib or R-EPOCH-R (Comprising Etoposide, Doxorubicin, Vincristine, Prednisone, Cyclophosphamide, and Rituximab) or Sirolimus Only or Observation or HAART Only in Patients With Multicentric Castleman's Disease Associated With Kaposi's Sarcoma-Associated Herpesvirus
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information
Alternate Title
Antiretroviral Therapy With or Without Bortezomib or Combination Chemotherapy and Rituximab or Sirolimus Only or Observation Only in Treating Patients With Castleman's Disease
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| No phase specified | Treatment | Active | 12 and over | NCI-04-C-0275
NCT00099073 |
Special Category:
NIH Clinical Center trial, NCI Web site featured trial Objectives Primary - Determine disease activity, as reflected by fever, thrombocytopenia, anemia, neutropenia, and lymphocytopenia; human and viral interleukin-6 levels; C-reactive protein; and Kaposi's sarcoma-associated herpesvirus (KSHV) viral loads, in patients with KSHV-associated multicentric Castleman's disease treated with high-dose zidovudine and valganciclovir, with or without bortezomib or R-EPOCH-R (comprising etoposide, doxorubicin, vincristine, prednisone, cyclophosphamide, and rituximab) or sirolimus only, or observation or HAART only.
- Correlate laboratory pathogenesis-related parameters with clinical and hematologic parameters in patients treated with these regimens.
Secondary - Determine, preliminarily, the therapeutic efficacy and toxicity of high-dose zidovudine and valganciclovir in these patients.
- Determine, preliminarily, the feasibility of risk-stratifying these patients according to disease parameters.
- Determine the overall survival of patients treated with these regimens.
- Determine symptom-free and progression-free survival of patients treated with these regimens.
- Correlate the efficacy of these regimens with disease activity in these patients.
Entry Criteria Disease Characteristics:
- Histologically confirmed Kaposi's sarcoma-associated herpesvirus-associated multicentric Castleman's disease
Prior/Concurrent Therapy:
Biologic therapy Chemotherapy Endocrine therapy Radiotherapy Surgery Patient Characteristics:
Age Performance status - ECOG 1-4* (groups II and III only)
- ECOG 4 (group IV only)
[Note: *ECOG 4 eligible for groups II or III only if disease was refractory to prior conventional cytotoxic chemotherapy with rituximab] Life expectancy Hematopoietic Hepatic Renal Other - Not pregnant or nursing
- Negative pregnancy test
- No grade IV toxicity unrelated to HIV, its treatment, or multicentric Castleman's disease that would preclude study therapy
- No other malignancy requiring concurrent treatment that would preclude study therapy or monitoring
- No other condition or circumstance that would preclude study participation
Expected Enrollment 30A total of 16-30 patients (8-14 for groups II and III and 0-2 for groups I and IV) will be accrued for this study within 3-5 years. Outcomes Primary Outcome(s)Natural history as assessed by constitutional symptoms, lymph node measurements and biochemical measurements every 3-6 months or whenever there are clinical changes suggestive of disease activity
Secondary Outcome(s)Efficacy of high-dose zidovudine and ganciclovir as assessed by lymph node measurements, constitutional symptoms, and biochemical assessments every 21 days during therapy
Outline Patients are assigned to 1 of 6 treatment groups based on disease status. - Group I (observation only): Patients with asymptomatic disease undergo observation only or observation in conjunction with highly active antiretroviral therapy (HAART), where appropriate.
- Group II (high-dose zidovudine [HDAZT] and valganciclovir [VGCV]): Patients with symptomatic disease that is not life threatening receive oral HDAZT four times daily and oral VGCV twice daily on days 1-21. Courses repeat every 21 days.
- Group III (bortezomib, HDAZT, and VGCV): Patients with continued symptomatic disease who are not responding to group II therapy receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and HDAZT and VGCV as in group II on days 1-21. Courses repeat every 21 days.
- Group IV (R-EPOCH-R): Patients with life-threatening disease receive R-EPOCH-R therapy comprising rituximab IV on days 1 and 5; etoposide IV over 24 hours, doxorubicin IV over 24 hours, and vincristine IV over 24 hours on days 1-4; oral prednisone once daily on days 1-5; cyclophosphamide IV over 15 minutes on day 5; and filgrastim (G-CSF) or pegfilgrastim subcutaneously (SC) once daily beginning on day 6 and continuing until blood counts recover. Treatment repeats every 21 days for up to 6 courses.
- Group V: Patients in group II or III who do not respond to treatment or patients who have Kaposi's sarcoma requiring therapy receive rituximab IV and doxorubicin hydrochloride liposome IV. Treatment repeats every 21 days for 3-6 courses. Patients then receive interferon alfa SC 3 times weekly for 6-12 months.
- Group VI: Patients not responding to HDAZT and VGCV with or without bortezomib, or for whom other co-morbid conditions require therapy (e.g., Kaposi's sarcoma), or any
disease severity (e.g., performance status) where R-EPOCH-R is considered too toxic, receive oral sirolimus once daily on days 1-21 in the absence of disease progression or unacceptable toxicity.
Trial Contact Information
Trial Lead Organizations NCI - Center for Cancer Research | | | | Robert Yarchoan, MD, Protocol chair | | | |
Trial Sites
|
|
|
|
| U.S.A. |
|
| Maryland |
|
| |
Bethesda |
|
| | | | | | | | | NCI - HIV and AIDS Malignancy Branch |
| | | Robert Yarchoan, MD | |
| | | Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office |
| | | Clinical Trials Office - Warren Grant Magnusen Clinical Center - NCI Clinical Trials Referral Office | |
|
Related Information Web site for additional information
Featured trial article
| Registry Information | | | Official Title | | Targeted Oncolytic Virotherapy And Natural History Study Of KSHV-Associated Multicentric Castleman's Disease With Laboratory And Clinical Correlates Of Disease Activity | | | Trial Start Date | | 2004-09-28 | | | Trial Completion Date | | 2018-12-31 (estimated) | | | Registered in ClinicalTrials.gov | | NCT00099073 | | | Date Submitted to PDQ | | 2004-09-28 | | | Information Last Verified | | 2009-07-05 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.  Back to Top |
|
